Does the use of a specific cognitive intervention for children with movement disorders improve functional outcomes following deep brain stimulation?

• Register: ISRCTN
• Last refreshed on: 8 May 2023
• Main ID: ISRCTN57997252
• Date of registration: 09/03/2016
• Prospective Registration: No
• Primary sponsor: King's College London (UK)
• Public title: Does the use of a specific cognitive intervention for children with movement disorders improve functional outcomes following deep brain stimulation?
• Scientific title: Randomised controlled trial using the cognitive orientation to occupational performance (CO-OP) intervention with paediatric hyperkinetic movement disorders following deep brain stimulation (DBS): a feasibility study
• Date of first enrolment: 25/09/2014
• Target sample size: 36
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN57997252
• Study type: Interventional
• Study design: Single-centre randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

England, United Kingdom

Contacts

• Name: Hortensia Gimeno

Key inclusion & exclusion criteria

Inclusion criteria: 1. Participants must express and evidence a willingness to participate
2. Sufficient receptive and expressive communication ability to follow simple instructions and engagement with treatment (including adequacy of English language)
3. Diagnosis of hyperkinetic movement disorder other than neurodegenerative conditions
4. Age 6-21 years
5. Manual Ability and Classification System (17) (MACS) levels IIII
6. Emerging skills in self-care such as starting to want to get undressed, brush own teeth, self-feed
7. Ability to mobilize independently
8. Requiring adult assistance to complete age appropriate activities. e.g. eating and drinking, toothbrushing, washing and dressing, making a sandwich, making a bed, etc
9. Cognitive ability of 6 years of age and IQ above 70 as assessed using the Wechsler Intelligence Scale for Children (WISC)
10. Deep Brain Stimulation in situ and without signs of infection
Exclusion criteria: 1. Pure spasticity or mixed phenotype when spasticity is dominant feature;
2. Dystonia arising due to a neurodegenerative condition
3. Scheduled for surgical treatment in the study period
4. Known signs of DBS infection

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Topic: Children, Neurological; Subtopic: Children (all Diagnoses), Neurological (all Subtopics); Disease: All Diseases, Neuro-muscular and Encephalitis
Nervous System Diseases
Hyperkinetic movement disorders

Intervention(s)

Participants are randomly allocated to one of two groups.

Intervention group: A trained occupational therapist on cognitive orientation to daily occupational performance (CO- OP), will visit the child's home to complete the intervention. CO-OP will be implemented with the child and main carers will be asked to be present so that the strategies and general approach can be implemented on a daily basis. When necessary written instructions will be provided for the child and/or family. The CO-OP intervention will employ the treatment manual produced after the developmental phase so that if several treating therapists employed, adherence to the protocol can be ensured. There will be up to 10 CO-OP sessions, lasting for 45 minutes to one hour, delivered once or twice a week. The sessions will be completed in the child’s natural environment (i.e., home). The sessions will be videoed and a random session chosen for scoring of therapist adherence to the protocol by a CO-OP expert.

Control group: Participants continue to receive treatment as usual for the duration of the study. This might include equipment provision, occupational therapy or physiotherapy.

Primary Outcome(s)

Quality of functional performance for chosen goals is measured using the Performance Quality Rating Scale (PQRS) at baseline, post-intervention and 3 months follow up.

Secondary Outcome(s)

1. Typical performance is measured using the Assessment of Motor and Process Skills (AMPS) questionnaire is measured at baseline, post intervention and 3 months follow up
2. Executive Function (Proxy reported) is measured using the Behaviour Rating Inventory of Executive Function (BRIEF) is measured at baseline, post intervention and 3 months follow up
3. Dystonia impairment is measured using the Burke-Fahn-Marsden Dystonia Rating Scale is measured at baseline, post intervention and 3 months follow up up
4. Goal acquisition (self-reported) is measured using the Canadian Occupational Performance Measure (COPM) is measured at baseline, post intervention and 3 months follow up
5. Executive function is measured using the Colour Word Interference Test is measured at baseline, post intervention and 3 months follow up
6. Executive function is measured using the Comprehensive Trail Making Test (CTMT) is measured at baseline, post intervention and 3 months follow up
7. Quality of life is measured using the EQ-5D is measured measured at baseline, post intervention and 3 months follow up
8. Goal acquisition is measured using the Goal Attainment Scale (GAS) is measured at baseline, post intervention and 3 months follow up
9. Self-care and mobility function ability (proxy reported) is measured using the Pediatric Evaluation of Disability Inventory Computerised Assessment Tool (PEDI-CAT) is measured at baseline, post intervention and 3 months follow up
10. Self efficacy (self-reported) is measured using the Self-Efficacy Gauge Measure - Paediatrics is measured at baseline, post intervention and 3 months follow up
11. Anxiety (self and proxy reported) is measured using the Spence Children's Anxiety Scale (parent and child versions) is measured at baseline, post intervention and 3 months follow up
12. Adaptive behaviour (proxy reported) is measured using the Adaptive Behavior Assessment System (ABAS) is measured at baseline, post intervention and 3 months follow up

Secondary ID(s)

17472

Source(s) of Monetary Support

National Institute for Health Research

Ethics review

Status:
Approval date:
Contact:

South Central - Oxford A Research Ethics Committee, 26/08/2014, ref: 14/SC/1159

Results

• Results available: Yes
• Date Completed: 28/02/2017